Sr. CRA, Oncology, IQVIA Biotech

IQVIA Argentina; Carlsbad (CA); On-site; USD 105,000 - 198,000; Full time

Job summary

IQVIA Biotech in the United States is seeking an experienced Senior Clinical Research Associate to independently manage and monitor clinical trial sites to ensure studies comply with study protocols, GCP, ICH, and regulatory requirements.

You will conduct site qualification, initiation, routine monitoring, and closeout visits, support patient recruitment, provide protocol training, and help maintain essential documents, monitoring reports, and multisite coordination.

Qualifications

• Bachelor’s degree in a scientific, healthcare, or related discipline.
• Minimum of 4 years of on-site clinical monitoring experience.
• Strong knowledge of GCP, ICH guidelines, FDA regulations, and clinical trial processes.
• Experience conducting monitoring visits across multiple phases of clinical research.
• Excellent organizational, communication, and problem-solving skills.
• Ability to effectively manage multiple priorities in a fast-paced environment.
• Proficiency with Microsoft Office applications and clinical trial systems.

Responsibilities

• Oversee site monitoring activities including site qualification, initiation, routine monitoring, and closeout visits.
• Collaborate with investigative sites to support patient recruitment and retention, and provide protocol training.
• Monitor and review source documents, data query resolution, and regulatory documents.
• Prepare timely, accurate monitoring reports and escalate quality or compliance issues as needed.
• Mentor junior CRAs through co-monitoring and training when applicable.

Skills

On-site clinical monitoring

GCP/ICH knowledge

FDA regulations

Project management

Microsoft Office & CTMS

Communication skills

Education

Bachelor’s degree in science or healthcare

Tools

CTMS

Microsoft Office

Job description

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.

Hiring Senior Clinical Research Associates

We are seeking an experienced Senior Clinical Research Associate to join our Clinical Monitoring team. In this role, you will independently manage and monitor clinical trial sites to ensure studies are conducted in compliance with study protocols, Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, regulatory requirements, and sponsor expectations.

As a key member of the study team, you will perform site monitoring activities including site qualification, initiation, routine monitoring, and closeout visits. You will partner closely with investigative sites to support patient recruitment and retention efforts, provide protocol and study-related training, and proactively identify and resolve quality or compliance issues.

The Sr CRA is responsible for overseeing site performance, tracking study milestones, reviewing source documentation, managing data query resolution, ensuring regulatory and essential documents are maintained, and documenting monitoring activities through timely and accurate reports. You will collaborate with cross-functional teams to support the successful execution of clinical trials and may mentor junior CRAs through co-monitoring and training activities.

Qualifications

• Bachelor’s degree in a scientific, healthcare, or related discipline (or equivalent combination of education and experience).
• Minimum of 4 years of on-site clinical monitoring experience.
• Strong knowledge of GCP, ICH guidelines, FDA regulations, and clinical trial processes.
• Experience conducting monitoring visits across multiple phases of clinical research.
• Excellent organizational, communication, and problem-solving skills.
• Ability to effectively manage multiple priorities in a fast-paced environment.
• Proficiency with Microsoft Office applications and clinical trial systems.

Preferred Skills

• Strong therapeutic area knowledge and protocol management experience.
• Proven ability to build productive relationships with investigative sites, sponsors, and internal study teams.
• Experience mentoring or supporting the development of junior clinical research professionals.

Join us in helping accelerate the development of innovative therapies that improve patient lives worldwide.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $105,100.00 - $197,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.